Iquix

Levofloxacin is a prescription medication used to treat certain bacterial infections such as pneumonia, chronic bronchitis, and infections of the sinuses, urinary tract, kidneys, prostate (a male reproductive gland), and skin. Levofloxacin belongs to a group of drugs called fluoroquinolone antibiotics which work by killing the bacteria causing infection.

This medication comes in tablet and liquid form and is usually taken once daily. 

Common side effects of levofloxacin include nausea, headache, dizziness, and diarrhea.

Levofloxacin is a prescription medication used to treat certain bacterial infections such as pneumonia, chronic bronchitis, and infections of the sinuses, urinary tract, kidneys, prostate (a male reproductive gland), and skin.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Vistakon Pharmaceuticals, LLC

Levofloxacin can cause side effects that may be serious or even cause death (see "Drug Precautions").

Levofloxacin can cause severe allergic reactions. Allergic reactions can happen in people taking fluoroquinolones, including levofloxacin, even after only 1 dose. Stop taking levofloxacin and get emergency medical help right away if you have any of the following symptoms of a severe allergic reaction:

• hives
• trouble breathing or swallowing
• swelling of the lips, tongue, face
• throat tightness or hoarseness
• rapid heartbeat
• faint
• skin rash

Skin rash may happen in people taking levofloxacin, even after only 1 dose. Stop taking levofloxacin at the first sign of a skin rash and call your healthcare provider. Skin rash may be a sign of a more serious reaction to levofloxacin.

Liver damage (hepatotoxicity) can happen in people who take levofloxacin. Call your doctor right away if you have unexplained symptoms such as:

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nausea or vomiting
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stomach pain
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fever
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weakness
•  
abdominal pain or tenderness
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itching
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unusual tiredness
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loss of appetite
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light colored bowel movements
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dark colored urine or yellowing of your skin or the whites of your eyes

Seizures have been reported in people who take fluoroquinolone antibiotics including levofloxacin. Tell your doctor if you have a history of seizures. Ask your doctor whether taking levofloxacin will change your risk of having a seizure. Central Nervous System (CNS) side effects may happen as soon as after taking the first dose of levofloxacin. Talk to your doctor right away if you get any of these side effects, or other changes in mood or behavior:

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seizures
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hear voices, see things, or sense things that are not there (hallucinations)
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feel restless
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tremors
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feel anxious or nervous
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confusion
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depression
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trouble sleeping
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nightmares
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feel lightheaded
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feel more suspicious (paranoia)
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suicidal thoughts or acts

Intestine infection (Pseudomembranous colitis). Pseudomembranous colitis can happen with most antibiotics, including levofloxacin. Call your doctor right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. You may have stomach cramps and a fever. Pseudomembranous colitis can happen 2 or more months after you have finished your antibiotic.

Changes in sensation and possible nerve damage (Peripheral Neuropathy). Damage to the nerves in arms, hands, legs, or feet can happen in people taking fluoroquinolones, including levofloxacin. Talk with your doctor right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:.

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pain
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burning
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tingling
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numbness
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weakness
  • Levofloxacin may need to be stopped to prevent permanent nerve damage.


Serious heart rhythm changes (QT prolongation and torsades de pointes). 
Tell your doctor right away if you have a change in your heart beat (a fast or irregular heartbeat), or if you faint. Levofloxacin may cause a rare heart problem known as prolongation of the QT interval. This condition can cause an abnormal heartbeat and can be very dangerous. The chances of this happening are higher in people:

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who are elderly
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with a family history of prolonged QT interval
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with low blood potassium (hypokalemia)
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who take certain medicines to control heart rhythm (antiarrhythmics)

Increased chance of problems with joints and tissues around joints in children can happen. Tell your child's healthcare provider if your child has any joint problems during or after treatment with levofloxacin.

Changes in blood sugar can occur. People who take levofloxacin and other fluoroquinolone medicines with oral anti-diabetes medicines or with insulin can get low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia). Follow your healthcare provider's instructions for how often to check your blood sugar. If you have diabetes and you get low blood sugar while taking levofloxacin, stop taking levofloxacin and call your healthcare provider right away. Your antibiotic medicine may need to be changed.

Sensitivity to sunlight (photosensitivity). 

The most common side effects of levofloxacin include:

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dizziness
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headache
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constipation
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nausea
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diarrhea

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, herbal and dietary supplements. Levofloxacin and other medicines can affect each other causing side effects. Especially tell your doctor if you take:

• an NSAID (Non-Steroidal Anti-Inflammatory Drug). Many common medicines for pain relief are NSAIDs. Taking an NSAID while you take levofloxacin or other fluoroquinolones may increase your risk of central nervous system effects and seizures. 
• an oral anti-diabetes medicine or insulin
• a blood thinner (warfarin, Coumadin, Jantoven)
• a medicine to control your heart rate or rhythm (antiarrhythmics). 
• an anti-psychotic medicine
• a tricyclic antidepressant
• a water pill (diuretic)
• a steroid medicine. Corticosteroids taken by mouth or by injection may increase the chance of tendon injury. 
• theophylline (Theo-24, Elixophyllin, Theochron, Uniphyl, Theolair)

Certain medicines may keep levofloxacin from working correctly. Take levofloxacin tablets or oral solution either 2 hours before or 2 hours after taking these products: an antacid, multivitamin, or other product that has magnesium, aluminum, iron, or zinc, sucralfate (Carafate), didanosine (Videx,Videx EC).

Levofloxacin, a fluoroquinolone antibiotic, can cause serious side effects. Some of these serious side effects could result in death.

If you have any of the following serious side effects while you take levofloxacin, get medical help right away. Talk with your healthcare provider about whether you should continue to take levofloxacin.

1.  Tendon rupture or swelling of the tendon (tendinitis).

• Tendon problems can happen in people of all ages who take levofloxacin. Tendons are tough cords of tissue that connect muscles to bones.
  Some tendon problems include pain, swelling, tears, and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites.
• The risk of getting tendon problems while you take levofloxacin is higher if you:
  • are over 60 years of age
  • are taking steroids (corticosteroids)
  • have had a kidney
  • heart or lung transplant
• Tendon problems can happen in people who do not have the above risk factors when they take levofloxacin.
• Other reasons that can increase your risk of tendon problems can include:
  • physical activity or exercise
  • kidney failure
  • tendon problems in the past, such as in people with rheumatoid arthritis (RA)
• Call your healthcare provider right away at the first sign of tendon pain, swelling or inflammation. Stop taking levofloxacin until tendinitis or tendon rupture has been ruled out by your healthcare provider. Avoid exercise and using the affected area.
  The most common area of pain and swelling is the Achilles tendon at the back of your ankle. This can also happen with other tendons. Talk to your healthcare provider about the risk of tendon rupture with continued use of levofloxacin. You may need a different antibiotic that is not a fluoroquinolone to treat your infection.
• Tendon rupture can happen while you are taking or after you have finished taking levofloxacin. Tendon ruptures have happened up to several months after people have finished taking their fluoroquinolone.
• Get medical help right away if you get any of the following signs or symptoms of a tendon rupture:
  • hear or feel a snap or pop in a tendon area
  • bruising right after an injury in a tendon area
  • unable to move the affected area or bear weight

2.  Worsening of myasthenia gravis (a problem that causes muscle weakness). Fluoroquinolones like levofloxacin may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.

Do not take levofloxacin if you have ever had a severe allergic reaction to an antibiotic known as a fluoroquinolone, or if you are allergic to any of the ingredients in levofloxacin. Ask your doctor if you are not sure. 

Levofloxacin can make you feel dizzy and lightheaded. Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how levofloxacin affects you.

Avoid sunlamps, tanning beds, and try to limit your time in the sun. Levofloxacin can make your skin sensitive to the sun (photosensitivity) and the light from sunlamps and tanning beds. You could get severe sunburn, blisters or swelling of your skin. If you get any of these symptoms while taking levofloxacin, call your doctor right away. You should use a sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of levofloxacin there are no specific foods that you must exclude from your diet when receiving levofloxacin.

Tell your doctor about all your medical conditions, including if you:

• have tendon problems
• have central nervous system problems (such as epilepsy)
• have nerve problems
• have or anyone in your family has an irregular heartbeat, especially a condition called "QT prolongation."
• have low blood potassium (hypokalemia)
• have a history of seizures
• have bone and joint problems
• have kidney problems. You may need a lower dose of levofloxacin if your kidneys do not work well.
• have liver problems
• have rheumatoid arthritis (RA) or other history of joint problems
• are pregnant or planning to become pregnant. It is not known if levofloxacin will harm your unborn child.
• are breast-feeding or planning to breast-feed. Levofloxacin is thought to pass into breast milk. You and your doctor should decide whether you will take levofloxacin or breast-feed.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, herbal and dietary supplements. Levofloxacin and other medicines can affect each other causing side effects. Especially tell your doctor if you take:

• an NSAID (Non-Steroidal Anti-Inflammatory Drug). Many common medicines for pain relief are NSAIDs. Taking an NSAID while you take levofloxacin or other fluoroquinolones may increase your risk of central nervous system effects and seizures. 
• an oral anti-diabetes medicine or insulin
• a blood thinner (warfarin, Coumadin, Jantoven)
• a medicine to control your heart rate or rhythm (antiarrhythmics). 
• an anti-psychotic medicine
• a tricyclic antidepressant
• a water pill (diuretic)
• a steroid medicine. Corticosteroids taken by mouth or by injection may increase the chance of tendon injury. 
• theophylline (Theo-24, Elixophyllin, Theochron, Uniphyl, Theolair)
• Certain medicines may keep levofloxacin from working correctly. Take levofloxacin tablets or oral solution either 2 hours before or 2 hours after taking these products: an antacid, multivitamin, or other product that has magnesium, aluminum, iron, or zinc, sucralfate (Carafate), didanosine (Videx,Videx EC).

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if levofloxacin will harm your unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if levofloxacin is excreted in human breast milk or if it will harm your nursing baby.

• Take levofloxacin exactly as prescribed by your doctor.
• Take levofloxacin at about the same time each day.
• Drink plenty of fluids while taking levofloxacin.
• Levofloxacin tablets can be taken with or without food.
• Take levofloxacin oral solution 1 hour before or 2 hours after eating.
• If you miss a dose of levofloxacin, take it as soon as you remember. Do not take more than one dose in one day.
• Levofloxacin for Injection is given to you by intravenous (I.V.) infusion into your vein, slowly, over 60 or 90 minutes, as prescribed by your doctor.

Do not skip any doses, or stop taking Levofloxacin even if you begin to feel better, until you finish your prescribed treatment, unless:

• you have tendon effects,
• you have a serious allergic reaction or
• your doctor tells you to stop.

This will help make sure that all of the bacteria are killed and lower the chance that the bacteria will become resistant to levofloxacin. If this happens, levofloxacin and other antibiotic medicines may not work in the future.

If you take too much levofloxacin, call your doctor or get medical help immediately.

Take levofloxacin exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you.

The usual dose of levofloxacin tablets or oral solution is 250 mg, 500 mg, or 750 mg by mouth every 24 hours, as indicated by infection. The usual dose of levofloxacin injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours, as indicated by infection. The duration of levofloxacin therapy is also indicated by infection.

In patients with poor kidney function, the dosage is adjusted.

If you take too much levofloxacin, call your doctor or poison control center right away, or get emergency treatment.

• Store levofloxacin film-coated tablets at 59° to 86° F (15°C to 30°C). Keep the container closed tightly.
• Store levofloxacin oral solution at 59° to 86° F (15°C to 30°C).
• Keep levofloxacin and all medicines out of the reach of children.

WARNING:

Fluoroquinolone products affected by the labeling changes include ciprofloxacin (Cipro, Bayer; and generics), extended-release ciprofloxacin (Cipro XR, Bayer; Proquin XR, Depomed), gemifloxacin (Factive, Oscient), levofloxacin (Levaquin, Ortho McNeil), moxifloxacin (Avelox, Bayer), norfloxacin (Noroxin, Merck), and ofloxacin (Floxin, Ortho McNeil; and generic).

Using levofloxacin injection increases the risk that you will develop tendinitis (swelling of a fibrous tissue that connects a bone to a muscle) or have a tendon rupture (tearing of a fibrous tissue that connects a bone to a muscle) during your treatment or for up to several months afterward. These problems may affect tendons in your shoulder, your hand, the back of your ankle, or in other parts of your body. Tendinitis or tendon rupture may happen to people of any age, but the risk is highest in people over 60 years of age. Tell your doctor if you have or have ever had a kidney, heart, or lung transplant; kidney disease; a joint or tendon disorder such as rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function); or if you participate in regular physical activity. Tell your doctor and pharmacist if you are taking oral or injectable steroids such as dexamethasone (Decadron, Dexpak), methylprednisolone (Medrol), or prednisone (Sterapred). If you experience any of the following symptoms of tendinitis, stop using levofloxacin injection, rest, and call your doctor immediately: pain, swelling, tenderness, stiffness, or difficulty in moving a muscle. If you experience any of the following symptoms of tendon rupture, stop using levofloxacin injection and get emergency medical treatment: hearing or feeling a snap or pop in a tendon area, bruising after an injury to a tendon area, or inability to move or to bear weight on an affected area.

Using levofloxacin injection may worsen muscle weakness in people with myasthenia gravis (a disorder of the nervous system that causes muscle weakness) and cause severe difficulty breathing or death. Tell your doctor if you have myasthenia gravis. Your doctor may tell you not to use levofloxacin injection. If you have myasthenia gravis and your doctor tells you that you should use levofloxacin injection, call your doctor immediately if you experience muscle weakness or difficulty breathing during your treatment.

Talk to your doctor about the risks of using levofloxacin injection.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with levofloxacin injection. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide